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COVID-19Phase 2NCT04824391

Efficacy, Immunogenicity and Safety of Inactivated ERUCOV-VAC Compared With Placebo in COVID-19

A Phase 2 study testing ERUCOV-VAC 3 µg/0.5 ml Vaccine and ERUCOV-VAC 6 µg/0.5 ml Vaccine in people with COVID-19, run by Health Institutes of Turkey at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective is to determine the efficacy, immunogenicity and safety of two different strengths (3 µg and 6 µg) of an inactivated COVID 19 Vaccine compared to placebo so that to demonstrate the efficacy and safety in prophylaxis of COVID-19. Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
ERUCOV-VAC 3 µg/0.5 ml Vaccine and ERUCOV-VAC 6 µg/0.5 ml Vaccine
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
250 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Feb 2021to 30 Mar 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • healthy Caucasian origin
  • accepting not to participate in another COVID-19 vaccine study until the end of the study
  • volunteers who do not plan to get a child in the next one year; the volunteer and the partner should use a reliable form of contraception (abstinence, condom, birth control implant, birth control pills used or IUD used by the partner) during the study for at least 1 year
  • female participants of childbearing potential (defined as any female who has experienced menarche and who is NOT surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months) must agree to be heterosexually inactive through 12 months after the first vaccination OR agree to consistently use any of the described methods of contraception from through 12 months after the first vaccination.
  • male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination
  • participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination
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  • the outcome of the following examinations should be clinically insignificant: medical and surgical history (hypo-, hypertension, allergy, other diseases, major surgery, micturition, defecation, sleep, illness within the last 4 weeks prior to the start of the trial);
  • life style and habits (consumption of alcohol, nicotine, coffee, tea, coke, special diet, drug abuse) should be normal/acceptable
  • body temperature, pulse rate, blood pressure and respiratory rate should be normal/acceptable.
  • laboratory examination (blood/serum examination: sodium, potassium, calcium, total protein, albumin, glucose, creatinine, BUN, total bilirubin, AST, ALT, GGT, ALP, haemoglobin, haematocrit, erythrocytes, Ieukocytes, platelet count; HBsAg, HIV-Ab, HCV-Ab should be normal/acceptable.
  • antiSARS CoV 2 total antibody (including COVID-19 IgG and/or IgM) negative in serum.
  • body weight in relation to height and age accepted BMI range 18.5 and 32 kg/m2 - both inclusive

Who cannot join

  • women with a positive blood (β-HCG) pregnancy test
  • lactating women
  • history of COVID-19 infection or showing COVID-19 infection symptoms
  • having had contact to people with known COVID-19 infection in the last 14 days
  • having fever (> 37.4oC in the last 24 hours), dry cough or feeling tired and having aches and pains, nasal congestion, runny nose, sore throat and diarrhea.
  • positive real time RT-PCR COVID-19 test.
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  • leukemia or neoplasm in history.
  • persons with autoimmune diseases
  • allergic diathesis or any clinically significant allergic disease (i.e. asthma)
  • any condition that might impair the immune response
  • recent or current immunosuppressive medication
  • any other vaccine application 30 days before the first dose
  • presence or a history of clinically significant cardiovascular, renal, hepatic, pulmonary, metabolic, endocrine, haematological, gastrointestinal, neurological, psychiatric or other major diseases;
  • disruption of platelets or other blood clotting disorders, which may cause contraindications to intramuscular administration
  • clinically significant illness within 4 weeks before the start of the study. Especially any acute or chronic illness seizures.
  • any regular intake or administration of any prescribed systemic or topical medication within 2 weeks prior to the start of the study; in the case of intake or administration of any prescribed systemic or topical medication within 4 weeks before the start of the study because of an insignificant illness, this should be stated in the CRF.
  • intake or administration of OTC medication (including herbal remedies) which may have an effect on the study according to the investigator within 2 weeks prior to the start of the study
  • volunteers who received antiviral drugs, immunoglobulins or blood transfusions or any other investigational drug within 4 weeks prior to the first study product administration
  • concomitant intake or administration of any systemic or topical drugs (including herbal remedies) on the application days
  • treatment with any investigational drug (i.e., drug not yet approved) in the last 4 weeks before beginning of the trial
  • medication with drugs known to alter organs or systems such as barbiturates, phenothiazines, cimetidine, omeprazole etc. within the last 1 month (4 weeks)
  • donation of blood or plasma more than 450 ml within the last 2 months (8 weeks) or any amount within the last month (4 weeks)
  • supine blood pressure, after resting for 5 min, higher than 140/90 or lower than 100/60 mmHg
  • supine pulse rate, after resting for 5 min, outside the range of 50 - 100 beats/min
  • supine respiratory rate, after resting for 5 min, outside the range of 15 - 18 breathings / min
  • laboratory values (appendix 5) outside normal range with clinical relevance at entry examination
  • alcohol abuse i.e. regular use of more than 2 units of alcohol per day or a history of alcoholism or drug/chemical abuse (one unit of alcohol equals ½ l of beer, 200 ml wine or 50 ml of spirits) or recovered alcoholics
  • caffeine abuse i.e. regular use of more than 750 mg/day caffeine
  • alcoholic or methylxanthine-containing beverages or foods (coffee, tea, coke, chocolate) and fruit-juice from 24 hours prior to each application
  • smoking of more than 10 cigarettes or equivalent per day, no smoking before application
  • vegetarian or any special diet due to any reason
  • knowledge to have any type of parenterally transmitted hepatitis or carrier of the HBsAg (HBsAg test positive)
  • HIV-Ab test positive
  • Test on anti-HCV antibodies positive
  • legal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible consequences of the study
  • evidence of an uncooperative attitude.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Erciyes University

    Kayseri, 38039

Other trials in Turkey (Türkiye)

About this study

Official title: Phase 2 Study for the Determination of Efficacy, Immunogenicity and Safety of Two Different Strengths of the Inactivated COVID-19 Vaccine ERUCOV-VAC, in a Placebo Controlled, Randomized, Double Blind Study Design.

The objective is to determine the efficacy, immunogenicity and safety of two different strengths (3 µg and 6 µg) of an inactivated COVID 19 Vaccine compared to placebo so that to demonstrate the efficacy and safety in prophylaxis of COVID-19. A 3rd application will be performed to approximately the half of the volunteers who were administered 3 μg/0.5 ml and who accept to be vaccinated for a 3rd time, on their month 4 visit.

Conditions
COVID-19
Being tested
ERUCOV-VAC 3 µg/0.5 ml Vaccine, ERUCOV-VAC 6 µg/0.5 ml Vaccine, Placebo
Keywords
COVID-19, Vaccine, Inactive, Phase 2
Medical subject headings
COVID-19, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ERUCOV-VAC 3 µg/0.5 ml VaccineBiological

    Two IM applications on Days 1 and 28

  • ERUCOV-VAC 6 µg/0.5 ml VaccineBiological

    Two IM applications on Days 1 and 28

  • PlaceboOther

    Two IM applications on Days 1 and 28

Study groups in NCT04824391
Study groupRoleWhat they receive
3 mcg/0.5 ml VaccineExperimentalLow dose vaccine
Receives: Biological: ERUCOV-VAC 3 µg/0.5 ml Vaccine
6 mcg/0.5 ml VaccineExperimentalMedium dose vaccine
Receives: Biological: ERUCOV-VAC 6 µg/0.5 ml Vaccine
PlaceboPlacebo comparatorPlacebo
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum IgG antibody levels specific for the SARS-CoV- 2 rS protein antigen(s)

    Measured: 12 months

  2. Neutralizing antibodies from microneutralization assay

    Measured: 12 months

  3. Blood levels of cytokines: TNF-α, IFN-γ, IL-2, IL-4, IL-5 and IL-6

    Measured: 12 months

Secondary outcomes (1)

  1. Adverse events

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2021
  2. Study start10 Feb 2021
  3. Primary completion11 Mar 2022
  4. Study completion30 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04824391
Sponsor's protocol ID
IDEAL00620-EU02-PK537-3
Status last verified
Feb 2023
First submitted
25 Mar 2021
Last updated
3 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ozdarendeli A, Sezer Z, Pavel STI, Inal A, Yetiskin H, Kaplan B, Uygut MA, Bayram A, Mazicioglu M, Unuvar GK, Yuce ZT, Aydin G, Aslan AF, Kaya RK, Koc RC, Ates I, Kara A. Safety and immunogenicity of an inactivated whole virion SARS-CoV-2 vaccine, TURKOVAC, in healthy adults: Interim results from randomised, double-blind, placebo-controlled phase 1 and 2 trials. Vaccine. 2023 Jan 9;41(2):380-390. doi: 10.1016/j.vaccine.2022.10.093. Epub 2022 Nov 22.

    PubMed 36460536

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ERUCOV-VAC 3 µg/0.5 ml Vaccine and ERUCOV-VAC 6 µg/0.5 ml Vaccine in people with COVID-19, run by Health Institutes of Turkey at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum IgG antibody levels specific for the SARS-CoV- 2 rS protein antigen(s) (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04824391, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.

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